Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The insulin receptor is dependent on magnesium and hypomagnesemia is associated with increased insulin resistance and decreased insulin secretion and action. Recent data suggest that hypomagnesemia may play a role in development of type 2 diabetes. Kidney transplantation patients have low plasma magnesium levels, partly due to treatment with calcineurin inhibitors. However, the role of magnesium in the development of post-transplant diabetes mellitus (PTDM) is unclear.
The present study addresses, whether hypomagnesemia is feasible to reverse by oral administration of magnesium.
The investigators wish to investigate whether oral magnesium supplementation is sufficient to increase magnesium levels in kidney transplant recipients, and if supplementation improves glycemic parameters as measured by an oral glucose tolerance test (OGTT).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mablet | Experimental | Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total. |
|
| Placebo | Placebo Comparator | Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mablet 360 mg | Drug | Slow-released magnesium hydroxide |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Magnesium retension at loading test | Difference in magnesium retension at magnesium loading test between before and after oral treatment. Retension defined as percentage of magnesium retained from intravenous magnesium sulphate. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose (mmol/L) | Change of fasting plasma glucose (mmol/L) between start and the end of supplementation. | Baseline (Before magnesium loading tests) |
| Insulin (mg/kg/min) | Change of insulin (mg/kg/min) in OGTT (after 2 hours) between start and the end of supplementation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rasmus K Carlsen, MD | Contact | 004723073544 | r.k.carlsen@studmed.uio.no | |
| Trond Jenssen, Prof, PhD | Contact |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo |
|
| 2 hours oral glucose tolerance test |
| C-peptide (nmol/L) | Change of C-peptide (nmol/L) in OGTT (after 2 hours) between start and the end of supplementation. | 2 hours oral glucose tolerance test |